Trial Information

A Randomized Phase II Trial of Navelbine/Epirubicin Versus Navelbine/Mitozantrone Versus Cyclophosphamide/Adriamycin as Preoperative Chemotherapy in Patients With > or = 3cm Diameter Early Breast Cancer

OBJECTIVES:

- Determine the efficacy of vinorelbine/epirubicin and vinorelbine/mitoxantrone in terms
of clinical objective tumor response, clinical complete remission, and pathological
complete remission in women with early stage breast cancer.

- Compare the efficacy of these 2 new regimens with an established regimen of
cyclophosphamide/doxorubicin in a randomly selected control group of patients.

- Compare the toxicity and side effects of these 2 new regimens in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to center and age (under 50 vs 50 and over). Patients are randomized to one of
three treatment arms.

- Arm I: Patients receive vinorelbine IV on days 1 and 8 and epirubicin IV on day 1.

- Arm II: Patients receive vinorelbine IV on days 1 and 8 and mitoxantrone IV on day 1.

- Arm III: Patients receive doxorubicin IV and cyclophosphamide IV on day 1. Treatment
continues every 3 weeks for 6 courses in the absence of unacceptable toxicity or
disease progression. All patients except those who are under 50 and whose tumors are
estrogen receptor negative receive oral adjuvant tamoxifen daily in addition to
chemotherapy.

All patients are offered surgery following completion of chemotherapy. Radiotherapy begins
within 4 weeks of completion of chemotherapy or surgery, whichever is the immediately
preceding treatment.

Patients are followed every 3 months for the first 2 years, every 6 months for the next 3
years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 62-125 patients will be accrued for this study within 12-18
months.